Levemir® Once-Daily Substantially Lowered Average Blood Sugar Levels of Patients with Type 2 Diabetes in TITRATE® Study
Approximately 60 Percent of Patients Reached American Diabetes Association's Recommended Average Blood Sugar Level
Princeton, NJ (May 8, 2009) /PRNewswire/ — Novo Nordisk today announced results from the TITRATE® study showing that Levemir® (insulin detemir [rDNA origin] injection), taken once-daily, substantially lowered average blood sugar. Type 2 diabetes patients took a more active role in their treatment by adjusting their own dosing, after being trained and given an adjustment schedule by their physician. Approximately 60 percent of patients taking Levemir® once-daily reached the American Diabetes Association's (ADA) recommended average blood sugar level.
"Teaching and empowering patients to adjust their own insulin doses can help them achieve good blood sugar control," said Lawrence Blonde, MD, Director, Ochsner Diabetes Clinical Research Unit, Department of Endocrinology, Diabetes and Metabolism at the Ochsner Medical Center, New Orleans and the lead researcher in the trial. "These findings showed that following a self-adjustment dosing schedule of Levemir® once-daily resulted in a majority of patients reaching the target blood sugar level that the ADA recommends for most patients."
The TITRATE® study was published this week online in the journal, Diabetes, Obesity & Metabolism.
Patients who had not previously used insulin and had a starting average blood sugar level (A1C) of less than 9 percent, adjusted their dose of Levemir® to reach specific fasting blood sugar targets of 70-90 mg/dL or 80-110 mg/dL. Fasting blood sugar is the amount of sugar in the blood as determined by a blood test (called FPG) taken first thing in the morning after not eating for at least 8 hours. The study showed that Levemir® taken once-daily substantially lowered patients' A1C levels after 20 weeks for both FPG targets tested.
In the study, 64.3 percent of patients in the 70-90 mg/dL FPG target treatment group and 54.5 percent of patients in the 80-110 mg/dL FPG target group reached the ADA recommended A1C level of less than 7 percent. A1C levels in the 70-90 mg/dL group decreased by 1.2 percent to an average A1C of 6.77 percent; A1C levels in the 80-110 mg/dL group decreased by 0.9 percent to an average A1C level of 7 percent.
"Good blood sugar control is important in managing diabetes, and the more active a role patients can play, the better," said Alan Moses, Vice President and Global Chief Medical Officer at Novo Nordisk. "This study is exciting because it showed that Levemir® at a once-daily dose helped these patients manage their condition, and in doing so, helped them achieve substantial A1C reductions."
Rates of minor hypoglycemic events were low and comparable between the two treatment groups (5.09 vs 3.16 events/patient/year in the 70-90 mg/dL and 80-110 mg/dL FPG target treatment groups, respectively). A single major hypoglycemic event (requiring third party assistance) was reported by a patient in the 70-90 mg/dL FPG target treatment group. More details about the study can be found in the journal. Prescribing information for Levemir® is available by contacting Novo Nordisk or visiting novonordisk-us.com.
About the Study
The open-label TITRATE® study was a prospective, randomized, controlled study to examine the effect of patients self dosing of Levemir® once-daily using two FPG targets on blood sugar control. In the study, 244 type 2 diabetes patients taking oral antidiabetes drugs, who had never before used insulin, were assigned to one of two treatment groups: using 70-90 mg/dL or 80-110 mg/dL as their fasting blood sugar targets. After being trained and given an adjustment schedule by their physician, patients continued their use of oral diabetes drugs and changed their insulin dose every three days. Levemir® was initiated at 0.1 to 0.2 unit/kg or 10 units once-daily at dinner or bedtime.
About Levemir® (insulin detemir [rDNA origin] injection)
Levemir® is indicated for once- or twice-daily subcutaneous administration for the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia.
Important safety information
Levemir® is contraindicated in patients hypersensitive to insulin detemir or one of its excipients.
Hypoglycemia is the most common adverse effect of all insulin therapies, including Levemir®. As with other insulins, the timing of hypoglycemic events may differ among various insulin preparations. Glucose monitoring is recommended for all patients with diabetes. Levemir® is not to be used in insulin infusion pumps. Any change of insulin dose should be made cautiously and only under medical supervision. Concomitant oral antidiabetes treatment may require adjustment.
Inadequate dosing or discontinuation of treatment may lead to hyperglycemia and, in patients with type 1 diabetes, diabetic ketoacidosis. Levemir® should not be diluted or mixed with any other insulin preparations. Insulin may cause sodium retention and edema, particularly if previously poor metabolic control is improved by intensified insulin therapy. Dose and timing of administration may need to be adjusted to reduce the risk of hypoglycemia in patients being switched to Levemir® from other intermediate or long-acting insulin preparations. The dose of Levemir® may need to be adjusted in patients with renal or hepatic impairment.
Other adverse events commonly associated with insulin therapy may include injection site reactions (on average, 3 percent to 4 percent of patients in clinical trials) such as lipodystrophy, redness, pain, itching, hives, swelling, and inflammation. Less common, but more serious are severe cases of generalized allergy, including anaphylactic reaction, which may be life threatening.
Levemir® is a registered trademark of Novo Nordisk A/S.
About Novo Nordisk
Novo Nordisk is a healthcare company with an 86-year history of innovation and achievement in diabetes care. The company has the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems. In addition to diabetes care, Novo Nordisk has a leading position within areas such as hemostasis management, growth hormone therapy, and hormone therapy for women. Novo Nordisk's business is driven by the Triple Bottom Line: a commitment to economic success, environmental soundness, and social responsibility to employees and customers. With headquarters in Denmark, Novo Nordisk employs more than 27,000 employees in 81 countries, and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol 'NVO'. For global information, visit novonordisk.com; for United States information, visit www.novonordisk-us.com.
For more information on the Ochsner Medical Center, go to www.ochsner.org.
© Novo Nordisk Inc. 137944 May 2009